APhA Proposes New "Pharmacy Care OTC" Category of Drugs

Author: Ken Rankin

The American Pharmacists Association
(APhA) is developing a new proposal
to create a third class of drugs,
which would be sandwiched between
prescription and OTC medicines and
available only at retail outlets staffed
by an on-premises pharmacist.

The products in the new category,
which APhA is calling "Pharmacy Care
OTCs," would include medications
"used for chronic, asymptomatic conditions
or other conditions where consumers
would benefit from additional
interaction with their pharmacist," a
representative from the association said.

In addition to enabling consumers
to "benefit from the expertise of pharmacists
to help them effectively utilize
these products," the establishment
of such a new class of drugs
would create "an opportunity for
pharmacists to play a greater role in
consumer medication use," an APhA
representative said.

Behind the new plan: the steady rise
in prescription-to-OTC drug switches
approved by the FDAincluding a
shift in the status of a number of
sophisticated and powerful pharmaceuticals
that are now available without
a prescription.

"In the past few years, a non-sedating
antihistamine, a full-strength H2
receptor antagonist, and a proton-pump
inhibitor have made this transition
to OTC status," an APhA executive
explained. "With the support of
consumers, manufacturers, and regulators,
all indications point to even more
products making the move - including
products for asymptomatic conditions
like osteoporosis or high cholesterol."

The plan for the new pharmacist-only
OTC category was developed by
an APhA Task Force, which is now
seeking comments on the proposal
from pharmacy professionals and others.
A final report from that group is
expected early in 2005.